Skip to main content
OpenTrials
Completed

NCT Number: NCT01246206

Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT

The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant.

Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years.

Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematological Malignancies Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suitable related donor as determined by the treating physician
  • High resolution molecular HLA typing is mandatory for HLA Class I and II
  • Diagnosis of hematological malignancy
  • Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol:
  • Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR)
  • Hodgkin disease, any CR/PR/stable disease (SD)
  • Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) any CR; for non-CR AML or ALL, bone marrow blast < 20% within 4 weeks of transplant and peripheral blood (PB) absolute blast count < 500/μl on the day of initiation of conditioning
  • Myelodysplastic syndrome (MDS), treated or untreated
  • Chronic myelogenous leukemia (CML) in chronic phase or accelerated phase
  • Chronic myelomonocytic leukemia (CMML)
  • Multiple myeloma, any CR/PR/SD
  • Chronic lymphocytic leukemia (CLL) any CR/PR
  • Myelofibrosis and other myeloproliferative disorders; bone marrow blasts less than 20 percent within four weeks of transplant and peripheral blood absolute blast counts less than 500 per microliter on the day of initiation of conditioning
  • Age >= 18 and able to cooperate with oral medication intake
  • Filgrastim (G-CSF) mobilized Peripheral blood stem cells
  • Agrees to participate, and informed consent signed
  • Karnofsky performance status (KPS) >= 60, Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Creatinine clearance > 60 mL/min
  • Ejection fraction > 50%
  • Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
  • Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted

Exclusion criteria

  • Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation [CD]34+ enrichment, T-cell depletion, etc)
  • Patients with documented uncontrolled central nervous system (CNS) disease
  • Active donor or recipient serology positive for human immunodeficiency virus (HIV)
  • Known contraindication to administration of Tacrolimus or Thymoglobulin
  • Active Hepatitis B or C
  • Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echocardiogram or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the Principal Investigator
  • Oxygen usage at the time of enrollment
  • Patients with clinical ascites
  • Women who are pregnant or nursing

Treatment and study plan

Tacrolimus and Thymoglobulin

Drug

Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.

Other names: PROGRAF®

Primary outcomes

  1. Incidence of Acute GVHD

    Time frame: Assessed first 6 months post transplant

    Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks

  2. Safety Defined by Serious Adverse Events

    Time frame: Assessed first 6 months post transplant

    Counted the number of participants that experienced any type of grade 3 or higher toxicity.

  3. Severity of Acute GVHD

    Time frame: Assessed first 6 months post transplant

    Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks

Secondary outcomes

  1. Determine Incidence of Opportunistic Infections

    Time frame: Followed for up to two years post transplant

  2. Estimate Incidence of Chronic GVHD at Two Years

    Time frame: Followed for up to two years post transplant

    Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks

  3. Overall Survival at Two Year,

    Time frame: Followed for up to two years post transplant

  4. Determine Time to Engraftment ("G500")

    Time frame: Followed for up to two years post transplant

    The number of days until engraftment ("G500")

  5. Determine Time to Engraftment ("PLT20")

    Time frame: Followed for up to two years post transplant

    The number of days until engraftment ("PLT20")

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Registry information

Official study title

A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 23, 2010
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.